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Abstract

Introduction: Task-shifting for male medical circumcision is proposed as a strategy to overcome the lack of surgeons and doctors in high HIV prevalence settings. We undertook a systematic review and meta-analysis to review the safety of task-shifting for circumcision in Africa.

Methods: We searched online databases and conference websites up to July 2011 without language restriction for studies reporting outcomes of task-shifting for circumcision in Africa. Information was extracted independently and in duplicate on study characteristics, quality, and outcome data. Case reports and case series were excluded.

Introduction

The protective effect of male circumcision on male acquisition of HIV infection is supported by strong evidence from randomized trials and observational studies [1,2]. Mathematical models estimate that widespread male circumcision in Africa could prevent up to 6 million new HIV infections and 3 million deaths in the next two decades [3]. Consequently, the WHO promotes male medical circumcision as a prevention intervention and has issued several guidelines to support the scaling up of male circumcision services [4,5].

The implementation of circumcision programs has been delayed in some countries by a number of challenges, including acceptability, ethical concerns, and practical constraints [6]. In high HIV prevalence countries in eastern and southern Africa, the lack of human resources is reported to be one of the most important limitations to scaling up male medical circumcision [7]. Many high HIV burden countries in Africa face an acute shortage of health workers. East Africa, for example, is estimated to have more than 20 times fewer surgeons per population compared with the United States [8]. The number of doctors is in similarly short supply [9].

Task-shifting – the planned delegation of tasks from higher level health cadres (specialists or doctors) to non-physician clinicians – has been promoted by the WHO to support expansion of HIV/AIDS treatment and care [10] and the safety and efficacy of task-shifting for antiretroviral therapy has been validated in randomized trials [11]. Task-shifting has also been proposed as a way to expand surgical capacity, particularly in resource-limited settings, [12] and is promoted by WHO as a potential solution to expanding male medical circumcision services [4]. However, evidence of the safety of circumcision carried out by nonphysicians is mixed. Some studies have concluded that outcomes of male medical circumcision performed by appropriately trained lay providers may be comparable to physicians, [13] whereas others assert that male circumcision should be limited to surgeons in medical facilities [14]. Partly as a result of this uncertainty, implementation of male medical circumcision is varied. Some countries have embraced task-shifting in the scale up of male circumcision; others are in the process of reviewing guidelines, whereas others still have yet to establish policy [7,15].

Several recent systematic reviews have assessed the frequency of adverse events following male medical circumcision [16,17], but none have specifically assessed task-shifting. We conducted a systematic review to assess the available evidence of safety of male medical circumcision by non-physician providers.

Methods

This systematic review was conducted according to the guidelines for reporting systematic reviews of observational studies by the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group [18].

Inclusion criteria

We defined task-shifting as the planned delegation of the surgical act of male medical circumcision to non-physician clinicians (i.e. any health worker below the level of doctor, such as medical officers, nurses, or trained lay workers). Studies in which male medical circumcision was done by non-specialists in an unplanned way (i.e. not accompanied by training and/or supervision) were excluded. Studies that included a team of providers were included provided that the majority (i.e. >70%) of the circumcision team were nonphysician clinicians.

Search strategy

We developed a search strategy that combined circumcision with the following terms: task shifting, nurs*, mid-level provider, physician assistant, clinical officers, birth attendant, and nonphysician clinician. We searched for studies that reported adverse events in randomized trials or observational cohorts in which adverse events were reported according to the level of health worker performing the circumcision. We restricted our review to studies done in Africa, as the region where male medical circumcision is predominately being rolled out for HIV prevention. We did not apply language or age restrictions.

We searched MEDLINE via PubMed, Embase, and Global Health (from inception to July 2011) and abstract databases of the International AIDS Society Conferences (up to July 2011, Rome), the Conferences on Retroviruses and Opportunistic Infections (up to February 2011, Boston), and the conferences of the International Society of Sexually Transmitted Disease Research (up to 2009, London). We complemented the search by reviewing bibliographies of relevant articles and contacting authors of previous reviews. Study authors were contacted to obtain additional information if needed.

Study selection and data abstraction

Two reviewers (N.F., K.C.) worked independently to assess eligibility and once all potentially relevant full-text articles and abstracts were identified, we consulted as a team (N.F., K.C) to achieve consensus regarding eligibility. Information was extracted independently and in duplicate, using a standardized form, on study setting, study populations, sample size, circumcision provider, location, training, and equipment. Our primary endpoint was complications of any kind; secondary endpoints were bleeding and infection. We further extracted the following information as an indicator of methodological quality and potential sources of confounding: duration of training, duration of follow-up, type of supervision, operation time, and provision of medical materials, enrollment criteria, and statistical adjustment for potential confounding.

Data analysis

We assessed interrater reliability on inclusion of articles by calculating a ϕ-statistic. The proportion of patients experiencing complications and 95% confidence intervals (CIs) were calculated for each study using a Freeman–Tukey arc-sin transformation [19]; given the small sample size of some included studies, we ran a sensitivity analysis calculating Agresti–Coull CIs for the primary meta-analysis of adverse events [20]. Relative risks were calculated for studies that reported adverse events disaggregated by provider. Results were pooled using the DerSimonian–Laird random effects method, which recognizes and anchors studies as a sample of all potential studies and incorporates an additional between-study component to the estimate of variability. We calculated the τ2-statistic for each analysis as a measure of the proportion of the overall variation that is attributable to between-study heterogeneity. Heterogeneity was examined using univariate subgroup analyses with χ2-test to assess the influence of location, provider, patient age, extent of training and supervision, and prior experience. We considered a P-value less than 0.05 to be significant. Analyses were conducted using StatsDirect (version 2.5.2; www.statsdirect.com) and Stata (version 11; StataCorp LP, College Station, Texas, USA).

Results

Of 1 885 citations initially screened, 33 studies were taken through for detailed evaluation. Twenty-three of these were excluded for one or more of the following reasons: three articles were reviews of other studies [16,17,21]; two studies were case series or retrospective reports with no clear denominator [22,23]; two studies were retrospective review of specific disorder [24,25]; adverse events were not reported in two studies [26,27]; four studies were excluded because male circumcision was done exclusively by physicians or higher cadres [28,29], or done by a lay provider but without task-shifting (i.e. no formal delegation/training by medical providers) [30,31]; five studies did not provide data disaggregated by provider and authors were unable to provide clarification [32–36]; two studies were excluded because the number of patients experiencing complications was unclear and authors were unable to provide clarification [37,38]; two studies were preliminary reports [39,40] of data subsequently reported in full [13,41]; and one study was excluded because only late complications were reported [42]. Figure 1 displays a flow diagram of the inclusion process. Agreement on study inclusions was high (ϕ=0.91).

Characteristics of studies

Ten studies were included in our analysis (see Table 1), giving information on 25 119 circumcisions. Three studies were from South Africa [43–45], two from Kenya [41,46], one from Comoros [13], one from Nigeria [47], one from Zambia [48], and two from Uganda [49,50]. Six studies were done in healthcare settings [41,45–48,50], with the remainder carried out in the community. Two studies described a task-sharing model in which a doctor was included as part of the team [43,45], the rest had lower cadres of health staff in charge. Eight studies reported outcomes among adults [41,43–46,48–50], the other two among children [13,47]. Two were conference abstracts [46,49].

Overall, we considered the methodological quality of studies included in this review to be moderate. Seven studies provided information on training, five on supervision, eight on duration of follow-up, five on operation time, and five on provision of medical materials. Two studies provided clear information on study inclusion criteria [41,50], and only one attempted statistical adjustment for potential confounding [50]. Details of service provision were limited, as information on prior experience, level of supervision, type of training, and provision and use of materials was provided only for a minority of studies (Table 2).

Adverse events

The proportion of adverse events ranged from 0.70 (95% CI 0.44–1.02%) to 37.36% (95% CI 27.54–47.72%), with an overall pooled proportion of 2.31% (95% CI 1.46–3.16%). Heterogeneity was high, as expected for proportions (τ2=1.21; P < 0.001) (Table 3 and Fig. 2). This proportion was no different if an alternative means of CI estimation was used (2.33, 95% CI 1.44–3.20). In our subgroup analyses, we did not find any difference in the frequency of adverse events comparing adults and children (P = 0.59), and comparing task-shifting and task-sharing models of circumcision (P = 0.36). Similarly, excluding the two task-sharing studies that included doctors [4,43] as part of the circumcision team did not alter the overall frequency of adverse events (2.59%, 95% CI 1.36–3.81). Circumcisions done in the community had a similar rate of complications compared with circumcisions done in healthcare settings (P = 0.11). Two studies reported outcomes separately for both doctors (2010 circumcisions) and nonphysician providers (3280 circumcisions) [47,50]; there was no difference in the risk of adverse events by provider (pooled relative risk 1.18; 95% CI 0.78–1.78). Two studies reported a high frequency of adverse events (>30%). One of these studies, from South Africa, reported that traditional surgeons and traditional nurses received a 5-day training, but over half of circumcisions were performed using a traditional spear rather than a surgical blade [43]. The second study, from Nigeria, provided no details of training [47].

The nature of complications was reported by six studies. The frequency of excessive bleeding ranged from 0.30 to 24.71% with an overall pooled prevalence of 0.55% (95% CI 0.13–0.97%). Infection occurred in 0.30–1.85% of cases, with an overall pooled proportion of 0.88% (95% CI 0.29–1.47%). Nearly all adverse events were reported to be non-severe and transient/reversible (Table 3).

Discussion

The safety of male medical circumcision done by lesser trained health cadres has been confused by reports of high rates of complications resulting from circumcisions done by lay providers with little or no formal training, supervision, or supportive equipment, [51] in some cases resulting in severe adverse events including amputation and death [52]. Such traditional practice should be understood as distinct from task-shifting, in which the act of male medical circumcision is formally delegated within in a supportive environment.

Our review of over 25 000 operations done by trained non-physician clinicians (nurses, midwives, surgical aids, and clinical officers) found a frequency of adverse events similar to the rates reported when circumcisions are carried out by doctors or specialists. A systematic review examining complications of male medical circumcision when performed by doctors, urologists, and surgeons reported a frequency of severe adverse events ranging from 0 to 2.5% for children and 0 to 33% for adolescents and adults [16]. Nearly all reported complications in our review were non-severe and reversible. Similarly encouraging results have been reported from nonclinical circumcision done elsewhere. A report from Israel of over 19 000 circumcisions undertaken predominately by trained ritual circumcisers found an adverse event rate of 0.34% [53].

We identified a large number of circumcisions resulting in a precise estimate of the frequency of adverse events. However, the limited duration of follow-up of some studies may have led to an under-reporting of longer term complications. Although most important adverse events would be apparent immediately following circumcision, infections are usually only apparent after a few days, whereas complications relating to sexual function would take even longer to ascertain. We used a broad search strategy that included conference abstracts and contacted authors for further information, but cannot rule out the potential for publication bias. Male medical circumcision services are being scaled up in a number of countries as part of HIV prevention, and we are aware of a considerable amount of unpublished data exist from routine programs that was unable to be included because data were not disaggregated by provider [54]. Nevertheless, we were able to include data from three studies that reported outcomes from programs designed to scale-up male medical circumcision services [45,46,50].

The safety of male medical circumcision is influenced by the quality of training and supervision, the availability of safe equipment, and the number circumcisions performed. A study from Uganda reported that the post-training rate of adverse events following circumcisions done by physicians fell from 8.8% for the first 20 procedures to 2.0% after 100 procedures had been performed [55]. This relationship was also reported by one of the studies included in this review, which found that complication rates averaged 3.8% for the first 100 procedures per provider and decreased to 0.7% after 400 procedures had been performed [41]; two studies included in this review also reported a reduction in time to complete a circumcision with increasing experience [41,50].

Our study highlights several directions for research. Future reports should be encouraged to report on all factors that may contribute to safety, including length and duration of training, the provision and use of supportive medical materials, the relative contribution of team members in which a skills mix is employed, the frequency of adverse events according to the relative experience of the practitioner, and a standardized approach to the reporting of adverse events. Finally, the cost of task-shifted male circumcision services should be further evaluated. A recent systematic review of five costing studies found male medical circumcision to be cost saving as an HIV-prevention intervention, but these studies did not assess potential savings made by task-shifting [56]. In some settings patients have been charged for services and turn instead to informal providers, with adverse consequences [32]. Thus, the provision of free care is an important way to reduce adverse events related to male medical circumcision, and task-shifting may be one way to reduce costs to the health service.

Conclusion

The potential impact of male medical circumcision in contributing to HIV prevention, together with the enduring shortage of specialized health staff, has led a number of high-burden countries, including Kenya, Mozambique, South Africa, Swaziland, and Zimbabwe, to scale-up male medical circumcision services through a model of task-shifting or task-sharing [7]. Our review provides reassurance that, with proper training and supervision, task-shifting of male medical circumcision to nonphysician clinicians can be done safely, with no increase in the frequency of adverse events.

Acknowledgements

Author contributions: N.F. and E.J.M. conceived the review. N.F. and K.C. carried out the search, study selection, and data extraction. N.F., K.C., and E.M. analyzed the results. All authors drafted the manuscript and approved the final version.

Funding

Conflicts of interest

All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years, and no other relationships or activities that could appear to have influenced the submitted work.

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